Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
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- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT06248398
- Record updated
- 17 February 2025
- Original description
The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment.Read full original descriptionShow less
The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment.
To do this, we will compare the two methods of insertion of the electrode holder, on 140 patients candidates for cochlear implantation randomized in two groups (70 conventional surgery versus 70 robot-assisted surgery). All patients will be recruited during 17 months, in our Ear, nose and throat (ENT) Department of the Pitié-Salpêtrière hospital group, the first center for adult patients established in France (on average 180 patients/year).
Patient will be followed for 9 months with clinical evaluation, imaging, audiometric, listening effort and quality of life assessments. These evaluations will be carried out preoperatively and postoperatively at 3 months and 6 months post-activation of the cochlear implant.
Inclusion: Adult patient ≥ 18 years old; Patients with an indication for uni or bilateral, simultaneous or sequential cochlear implantation: severe to profound bilateral deafness with intelligibility ≤70% for Fournier dissyllabic words, in free field, at 60dB with adapted hearing aids; Patient able to understand the information note and give written consent; Affiliation to a French social security system.
Exclusion: Impossibility of testing the effect of the cochlear implant alone on hearing results (cochlear implantation in the context of unilateral deafness or fluctuating deafness); Patient who does not speak French; Etiologies of deafness known to be of bad prognosis (auditory neuropathy, congenital profound deafness, immediate post-meningitis profound deafness, vestibular schwannoma on the side of the ear to be implanted); Cochlear implantation requiring the use of a perimodiolar electrode holder; Pregnant and breastfeeding women; Patients wearing electronic devices, in direct connection with the brain or nervous system; Patient included in another interventional study (Jardé 1); Patient under legal protection (guardianship or curatorship) or deprived of liberty.